Impact of ERAS in LSG

NCT ID: NCT04442568

Last Updated: 2020-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-06-01

Brief Summary

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Patients with BMI \>35 and chronic diseases or BMI \>40 will be scheduled to receive Laparoscopic Sleeve Gastrectomy (LSG). Two groups are planned according to receive Enhance recovery after surgery (ERAS) protocol or not. All participants will receive standard LSG. Participants of ERAS will receive anesthesia and post-surgical nutrition protocol which are determined for ERAS. All patients will be checked for status of pain with VAS score, nausea and vomiting with PONV score at postoperative 2nd hour, 12th hour. In ERAS group liquid oral intake will be started between postoperative 2nd and 4th hours. In no ERAS group liquid oral intake will be started in the morning of postoperative first day. The patients who provides discharge criterias will be discahrged. these criterias are; To provide adequate pain relief with paracetamol and nonsteroidal painkillers, No wound problem, No complications after surgery, Pulse rate \<90 beats / min, temperature ≤ 37 · 5 ° C, respiratory rate, \<20 breaths / minute, To be able to mobilize easily, To be able to drink 1 liter of water after surgery.

Emergency admissions of the participants within a month after surgery will be recorded.

Detailed Description

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Conditions

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Laparoscopic Sleeve Gastrectomy Enhanced Recovery After Surgery Pain, Postoperative Nausea, Postoperative Vomiting, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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ERAS

all patients in this group will be performed LSG under a specified anesthesia protocol. This protocol includes non-opioid analgesia and sedation. Also short-acting anesthetic drugs will be used in this arm. The patients in this arm will be mobilized in the second hour postoperatively, also will be started oral intake between second and fourth hours.

Group Type ACTIVE_COMPARATOR

ERAS

Intervention Type OTHER

early mobilisation, early oral intake, early discharge

no ERAS

all patients in this group will be performed LSG under a conventional anesthesia protocol which is depended on the anesthesiologist . This protocol includes opioid analgesia and sedation. Also short and long acting anesthetic drugs will be used in this arm. The patients in this arm will be mobilized in the fourth hour postoperatively, also will be started oral intake in the next day morning after surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ERAS

early mobilisation, early oral intake, early discharge

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* must be performed laparoscopic sleeve gastrectomy
* body mass index \> 35 with a comorbidıty or ,body mass index \> 40

Exclusion Criteria

* surgery with peroperative complication
* revision surgery applications
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Abdullah Sisik

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Demirpolat MT, Sisik A, Yildirak MK, Basak F. Enhanced Recovery After Surgery Promotes Recovery in Sleeve Gastrectomy: A Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2023 May;33(5):452-458. doi: 10.1089/lap.2022.0494. Epub 2022 Dec 26.

Reference Type DERIVED
PMID: 36576984 (View on PubMed)

Other Identifiers

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ERAS-LSG

Identifier Type: -

Identifier Source: org_study_id

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